Pharmacodynamics Aspects Of Porcine Heparin Sodium, Produced by Eurofarma, Compared Heparin Sodium, Produced by APP Pharmaceuticasls, in Patients With Chronic Renal Failure
Background: Heparin forms a complex with a plasma protein, antithrombin III (ATIII) is an endogenous anticoagulant. This complex inhibits the formation of thrombin and accelerates its destruction. In addition, heparin and ATIII inactivate other proteases of the coagulation cascade, especially the anti-activated factor X. The outcome of these biochemical actions is the inhibition of the formation and synthesis of activators of the clotting factors that exert critical functions in the genesis of the blood clot. Patients with chronic renal failure (CRF) that make use of hemodialysis need a system of anticoagulation with direct inhibitors of thrombin and / or heparinoids to prevent thrombosis.
Based on clinical studies, the control of plasma heparin level in patients with CRF is essential. Coagulation tests such as APTT, PT, ChT and evidence of activity of anti-Xa factor to be used as a substrate for protection for those patients undergoing hemodialysis.
- Objective: Check the non-inferiority clinical, the pharmacodynamic effect and safety in use of the drug heparin of porcine origin, produced by the Laboratory Eurofarma, having as the active comparator drug APP ® Heparin Sodium (heparin - APP Pharmaceuticals) in patients with renal failure who do hemodialysis treatment.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Anticipato)
Fase
- Fase 2
- Fase 3
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Adults of both sexes, regardless of color or social class;
- Age over 18 years, with good clinical doctor's discretion;
- Patients research that agree to participate in the study and sign the informed consent form (attached);
- Chronic renal failure patients in hemodialysis (3 times per week). chronic renal failure patients with indication for anticoagulation during dialysis
Exclusion Criteria:
- Non compliance with the terms described in the informed consent FICT;
- Patients suffering from sensitivity studies heparin sodium;
- Patients with hypersensitivity to search benzyl alcohol;
- Patients with search history of bleeding disorders or disease that a bleeding disorder can worsen or terminate the clinical picture, for example, frames of gastric ulcer;
- Patients with a history of research peptic ulcer;
- Patient with cancer research because of the possibility of impairment of variable coagulation function;
- Patients who are research during pregnancy and postpartum;
- Individuals with a genetic abnormality of the coagulation system;
- Trauma patients;
- Patients on glucocorticoid therapy for at least 1 month;
- Patients using other anticoagulants;
- Patients with a high rate of bleeding;
- Patients undergoing any surgery performed less than 15 days due to the risk of bruising at the site of surgery.
- Patients using drugs that affect hemostasis
- Patients using the following drugs: Salicylates systemic aspirin and other NSAIDs, including ketorolac, Dextran 40, ticlopidine and clopidogrel, systemic glucocorticoids, thrombolytic agents and anticoagulants and other antiplatelet agents, including antagonists of glycoprotein IIb / IIIa.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Heparin sodium - APP
5000UI / mL
|
5000UI /mL
5000UI/mL
|
|
Sperimentale: Heparin - Eurofarma
5000 UI/ mL
|
5000UI /mL
5000UI/mL
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Effect (activity) of heparin observed for markers for aPTT and anti-Xa.
Lasso di tempo: 12 hemodialysis sessions in a row. The sessions take place 3 times a week. So be 4 weeks.
|
12 hemodialysis sessions in a row. The sessions take place 3 times a week. So be 4 weeks.
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Effectiveness in maintaining the absence clotting during hemodialysis.
Lasso di tempo: 12 consecutive sessions
|
12 consecutive sessions
|
|
Safety in use of the drug by monitoring events complicating the use of heparin
Lasso di tempo: 12 consecutive sessions
|
12 consecutive sessions
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- HEPEUR1009
- Version 01
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Suine
-
Genzyme, a Sanofi CompanyDiacrin/Genzyme Corporation LLCCompletato
-
University of CopenhagenSvineafgiftsfonden; DC Ingredients; Arla Food Ingredients Group P/SCompletatoFame | Risposta di sazietà | Sintesi proteicaDanimarca